Nadolol

Product NDC
76282-349
11-digit product format
762820349
Labeler code
76282
Product ID
76282-349_21acaed7-dd88-4da4-a60a-bbc9c33cadac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nadolol
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals Inc.
Application
ANDA203455
Marketing category
ANDA
Marketing start
2020-07-27
Substance
NADOLOL
Active strength
80 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nadolol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NADOLOL80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFEN504330V
Rxcui198006, 198007, 198008

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c3e14ce3-3dd7-c88b-aff9-2af221ac8a37Product name920240606
8fcb295c-5817-6981-e90d-9999d4e8f347Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-349-01Nadolol100 in 1 BOTTLETABLET1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-349NADOLOL TABLET [EXELAN PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 1 package rows20240330_5c6737f8-8fd8-4d8f-a66a-e99d3b64e1dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198006nadolol 20 MG Oral TabletPSN5c6737f8-8fd8-4d8f-a66a-e99d3b64e1dd2
198007nadolol 40 MG Oral TabletPSN5c6737f8-8fd8-4d8f-a66a-e99d3b64e1dd2
198008nadolol 80 MG Oral TabletPSN5c6737f8-8fd8-4d8f-a66a-e99d3b64e1dd2
198006nadolol 20 MG Oral TabletSCD5c6737f8-8fd8-4d8f-a66a-e99d3b64e1dd2
198007nadolol 40 MG Oral TabletSCD5c6737f8-8fd8-4d8f-a66a-e99d3b64e1dd2
198008nadolol 80 MG Oral TabletSCD5c6737f8-8fd8-4d8f-a66a-e99d3b64e1dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-349-0176282034901100 TABLET in 1 BOTTLE (76282-349-01) 100 tablet2020-07-270000-00-00NoNoCurrent